(a) It is unlawful for any person to practice or offer to
practice pharmacy or practice or offer to assist in the practice of
pharmacy in this state without a license or certification, issued
under this article, or advertise or use any title or description
tending to convey the impression that they are a pharmacist or
pharmacy technician, unless such person has been licensed or
certified under this article.

(b) A business entity may not render any service or engage in
any activity which, if rendered or engaged in by an individual,
would constitute the practice of pharmacy, except through a
licensee.

(c) It is unlawful for the proprietor of a pharmacy or a
ambulatory health care facility to permit any person not a licensed
pharmacist to practice pharmacy.

(d) It is unlawful for a charitable clinic pharmacy to permit
any person not a licensed practitioner to prescribe or dispense
pharmaceuticals.

§30-5-2. Applicable law.

The practices authorized under this article and the Board of
Pharmacy are subject to article one of this chapter, this article,
and any rules promulgated hereunder.

(2) “Active ingredients” means chemicals, substances, or other
components of articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in humans or
animals or for use as nutritional supplements.

(3) "Administer" means the direct application of a drug to the
body of a patient or research subject by injection, inhalation,
ingestion or any other means.

(4) “Adulterated”: A drug or device shall be deemed to be
adulterated:

(A) If:

(i) It consists, in whole or in part, of any filthy, putrid,
or decomposed substance; or

(ii) It has been produced, prepared, packed, or held under
unsanitary conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to health; or
if the methods used in, or the facilities or controls used for its
manufacture, processing, packing, or holding do not conform to or
are not operated or administered in conformity with current good
manufacturing practices to ensure that the drug or device meets the
requirements of this part as to safety and has the identity and
strength, and meets the quality and purity characteristics that it
purports or is represented to possess; or

(iii) Its container is composed, in whole or in part, of any
poisonous or deleterious substance that may render the contents
injurious to health; or

(iv) It bears or contains, for purposes of coloring only, a
color additive that is unsafe within the meaning of the Federal
Food, Drug, and Cosmetic Act; or it is a color additive, the
intended use of which is for purposes of coloring only, and is
unsafe within the meaning of the act;

(B) If it purports to be or is represented as a drug, the name
of which is recognized in an official compendium, and its strength
differs from, or its quality or purity falls below, the standard
set forth in the compendium. Such a determination as to strength,
quality, or purity shall be made in accordance with the tests or
methods of assay set forth in the compendium, or in the absence of
or inadequacy of these tests or methods of assay, those prescribed
under authority of the act. No drug defined in an official
compendium shall be deemed to be adulterated under this paragraph
because it differs from the standard of strength, quality, or
purity therefore set forth in the compendium, if its difference in
strength, quality, or purity from that standard is plainly stated
on its label. Whenever a drug is recognized in both the United
States Pharmacopeia (USP) and the Homeopathic Pharmacopoeia of the
United States it shall be subject to the requirements of the USP
unless it is labeled and offered for sale as a homeopathic drug, in
which case it shall be subject to the Homeopathic Pharmacopoeia of
the United States and not those of the USP;

(C) If it is not subject to paragraph ii and its strength
differs from, or its purity or quality falls below, that which it
purports or is represented to possess; or

(D) If it is a drug and any substance has been mixed or packed
therewith so as to reduce its quality or strength or substituted
wholly or in part thereof.

(5) “Authorization” means a license, certificate, registration
or permit issued under this article.

(6) "Board" means the West Virginia Board of Pharmacy.

(7) "Brand name" means the proprietary or trade name selected
by the manufacturer and placed upon a drug or drug product, its
container, label or wrapping at the time of packaging.

(8) “Chain pharmacy warehouse” means a permanent physical
location for drugs and devices that act as a central warehouse and
performs intracompany sales and transfers of prescription drugs or
devices to chain pharmacies, which are members of the same
affiliated group, under common ownership and control.

(10) "Collaborative pharmacy practice" is that practice of
pharmacy where one or more pharmacists have jointly agreed, on a
voluntary basis, to work in conjunction with one or more physicians
under written protocol where the pharmacist or pharmacists may
perform certain patient care functions authorized by the physician
or physicians under certain specified conditions and limitations.

(11) "Collaborative pharmacy practice agreement" is a written
and signed agreement between a pharmacist, a physician and the
individual patient, or the patient’s authorized representative who
has granted his or her informed consent, that provides for
collaborative pharmacy practice for the purpose of drug therapy
management of a patient, which has been approved by the board, the
Board of Medicine in the case of an allopathic physician or the
West Virginia Board of Osteopathy in the case of an osteopathic
physician.

(12)”Common carrier” means any person or entity who
undertakes, whether directly or by any other arrangement, to
transport property including prescription drugs for compensation.

(13) “Component” means any active ingredient or added
substance intended for use in the compounding of a drug product,
including those that may not appear in such product.

(14) "Compounding" means:

(A) The preparation, mixing, assembling, packaging or labeling
of a drug or device:

(i) As the result of a practitioner's prescription drug order
or initiative based on the practitioner/patient/pharmacist
relationship in the course of professional practice for sale or
dispensing; or

(ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing; and

(B) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
prescribing patterns.

(15) "Confidential information" means information maintained
by the pharmacist in the patient record or which is communicated to
the patient as part of patient counseling or which is communicated
by the patient to the pharmacist. This information is privileged
and may be released only to the patient or to other members of the
health care team and other pharmacists where, in the pharmacists'
professional judgment, the release is necessary to the patient's
health and well-being; to health plans, as that term is defined in
45 C.F.R. §160.103, for payment; to other persons or governmental
agencies authorized by law to receive the privileged information;
as necessary for the limited purpose of peer review and utilization
review; as authorized by the patient or required by court order.

(16) "Deliver" or "delivery" means the actual, constructive or
attempted transfer of a drug or device from one person to another,
whether or not for a consideration.

(17) "Device" means an instrument, apparatus, implement or
machine, contrivance, implant or other similar or related article,
including any component part or accessory, which is required under
federal law to bear the label, "Caution: Federal or state law
requires dispensing by or on the order of a physician."

(18) “Digital signature” means an electronic signature based
upon cryptographic methods of originator authentication, and
computed by using a set of rules and a set of parameters so that
the identity of the signer and the integrity of the data can be
verified.

(19) "Dispense" or "dispensing" means the preparation and
delivery of a drug or device in an appropriately labeled and
suitable container to a patient or patient's representative or
surrogate pursuant to a lawful order of a practitioner for
subsequent administration to, or use by, a patient.

(20) “Distribute” or “distribution” means to sell, offer to
sell, deliver, offer to deliver, broker, give away, or transfer a
Drug, whether by passage of title, physical movement, or both. The
term does not include:

(A) To dispense or administer;

(B) (i) Delivering or offering to deliver a drug by a common
carrier in the usual course of business as a common carrier; or

providing a drug sample to a patient by a practitioner licensed to
prescribe such drug;

(ii) A health care professional acting at the direction and
under the supervision of a practitioner; or the pharmacy of a
hospital or of another health care entity that is acting at the
direction of such a practitioner and that received such sample in
accordance with the act and regulations to administer or dispense.

(21) "Drug" means:

(A) Articles recognized as drugs by the food and drug
administration in the USP-DI, facts and comparisons, physician’s
desk reference or supplements thereto for use in the diagnosis,
cure, mitigation, treatment or prevention of disease in human or
other animals;

(B) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
and

(C) Articles intended for use as a component of any articles
specified in paragraph (A) or (B) of this subdivision.

(22) "Drug regimen review" includes, but is not limited to,
the following activities:

(B) Evaluation of the prescription drug orders and patient
records for duplication of therapy.

(C) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:

(i) Drug-drug;

(ii) Drug-food;

(iii) Drug-disease; and

(iv) Adverse drug reactions.

(D) Evaluation of the prescription drug orders and patient
records for proper use, including overuse and underuse and optimum
therapeutic outcomes.

(23) "Drug therapy management" means the review of drug
therapy regimens of patients by a pharmacist for the purpose of
evaluating and rendering advice to a physician regarding adjustment
of the regimen in accordance with the collaborative pharmacy
practice agreement. Decisions involving drug therapy management
shall be made in the best interest of the patient. Drug therapy
management shall be limited to:

(A) Implementing, modifying and managing drug therapy
according to the terms of the collaborative pharmacy practice
agreement;

(D) Ordering screening laboratory tests that are dose related
and specific to the patient's medication or are protocol driven and
are also specifically set out in the collaborative pharmacy
practice agreement between the pharmacist and physician.

(24) "Electronic data intermediary" means an entity that
provides the infrastructure to connect a computer system, hand-held
electronic device or other electronic device used by a prescribing
practitioner with a computer system or other electronic device used
by a pharmacy to facilitate the secure transmission of:

(A) An electronic prescription order;

(B) A refill authorization request;

(C) A communication; or

(D) Other patient care information.

(25) “E-prescribing” means the transmission, using electronic
media, of prescription or prescription-related information between
a practitioner, pharmacist, pharmacy benefit manager or health plan
as defined in 45 C.F.R. §160.103, either directly or through an
electronic data intermediary. E-prescribing includes, but is not
limited to, two-way transmissions between the point of care and the
pharmacist. E-prescribing may also be referenced by the terms
“electronic prescription” or “electronic order.”

(26) “Electronic Signature” means an electronic sound, symbol,
or process attached to or logically associated with a record and
executed or adopted by a person with the intent to sign the record.

(27) “Electronic transmission” means transmission of
information in electronic form or the transmission of the exact
visual image of a document by way of electronic equipment.

(28) “Emergency medical reasons” include, but are not limited
to, transfers of a prescription drug by one pharmacy to another
pharmacy to alleviate a temporary shortage of a prescription drug;
sales to nearby emergency medical services, ie, ambulance companies
and firefighting organizations in the same state or same marketing
or service area, or nearby licensed practitioners of prescription
drugs for use in the treatment of acutely ill or injured persons;
and provision of minimal emergency supplies of prescription drugs
to nearby nursing homes for use in emergencies or during hours of
the day when necessary prescription drugs cannot be obtained.

(29) “Equivalent Drug product” means a drug product which has
the same established name, active ingredient(s), strength or
concentration, dosage form, and route of administration and which
is formulated to contain the same amount of active ingredient(s) in
the same dosage form and to meet the same compendial or other
applicable standards (e.g., strength, quality, purity, and
identity)and is approved by the United States Food and Drug
Administration, but which may differ in characteristics, such as
shape, scoring, configuration, packaging, excipients (including
colors, flavors, and preservatives), and expiration time.

(30) “Exclusive distributor” means an entity that:

(A) Contracts with a manufacturer to provide or coordinate
warehousing, wholesale distribution, or other services on behalf of
a manufacturer and who takes title to that manufacturer’s
prescription drug, but who does not have general responsibility to
direct the sale or disposition of the manufacturer’s prescription
drug; and

(B) Is licensed as a wholesale distributor under this chapter.
(31) “FDA” means Food and Drug Administration, a federal
agency within the United States Department of Health and Human
Services.

(32) "Generic name" means the official title of a drug or drug
combination for which a new drug application, or an abbreviated new
drug application, has been approved by the FDA.

(33) “Health care entity” means any person that provides
diagnostic, medical, surgical, dental treatment, or rehabilitative
care but does not include any retail pharmacy or wholesale
distributor.

(34) “Health information” means any information, whether oral
or recorded in any form or medium, that:

(A) Is created or received by a health care provider, health
plan, public health authority, employer, life insurer, school or
university, or health care clearinghouse; and

(B) Relates to the past, present, or future physical or mental
health or condition of an individual; or the past, present, or
future payment for the provision of health care to an individual.

(35) “HIPAA” is the federal Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191).

(36) “Immediate container” means a container and does not
include package liners.

(37) “Individually identifiable health information” is
information that is a subset of health information, including
demographic information collected from an individual and is created
or received by a health care provider, health plan, employer, or
health care clearinghouse; and relates to the past, present, or
future physical or mental health or condition of an individual; the
provision of health care to an individual; or the past, present, or
future payment for the provision of health care to an individual;
and that identifies the individual; or with respect to which there
is a reasonable basis to believe the information can be used to
identify the individual.

(38) “Intracompany transaction” means any transaction between
a division, subsidiary, parent, and/or affiliated or related
company under the common ownership and control of a corporate
entity.

(39) “Label” means a display of written, printed, or graphic
matter upon the immediate container of any drug or device.

(40) "Labeling" means the process of preparing and affixing a
label to a drug container exclusive, however, of a labeling by a
manufacturer, packer or distributor of a nonprescription drug or
commercially packaged legend drug or device.

(43) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.

(44) "Manufacturing" means the production, preparation,
propagation or processing of a drug or device, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis and
includes any packaging or repackaging of the substance or
substances or labeling or relabeling of its contents and the
promotion and marketing of the drugs or devices. Manufacturing
also includes the preparation and promotion of commercially
available products from bulk compounds for resale by pharmacies,
practitioners or other persons.

(45) “Medical order” means a lawful order of a practitioner
that may or may not include a prescription drug order.

(46) “Medication therapy management” is a distinct service or
group of services that optimize therapeutic outcomes for individual
patients. Medication therapy management services are independent
of, but can occur in conjunction with, the provision of a
medication or a medical device. Medication therapy management
encompasses a broad range of professional activities and
0responsibilities within the licensed pharmacist’s scope of
practice. These services may include, but are not limited to, the
following, according to the individual needs of the patient:

(F) Documenting the care delivered and communicating essential
information to the patient’s other primary care providers;

(G) Providing verbal education and training designed to
enhance patient understanding and appropriate use of his or her
medications;

(H) Providing information, support services and resources
designed to enhance patient adherence with his or her therapeutic
regimens;

(I) Coordinating and integrating Medication Therapy Management
services within the broader health care management services being
provided to the patient; and

(J) Such other patient care services as may be allowed by law.

(47) “Misbranded”: A drug or device shall be deemed to be
misbranded if the label is false or misleading in any particular;
or the label does not bear the name and address of the
manufacturer, packer, or distributor and does not have an accurate
statement of the quantities of the active ingredients in the case
of a drug; or the label does not show an accurate monograph for
prescription drugs.

(48) "Nonprescription drug" means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws and rules of this
state and the federal government.

(49) “Normal distribution channel” means a chain of custody
for a prescription drug that goes from a manufacturer of the
prescription drug, the manufacturer’s third-party logistics
provider, or the manufacturer’s exclusive distributor to:

(A) A wholesale distributor to a pharmacy to a patient or
other designated persons authorized by law to dispense or
administer such prescription drug to a patient; or

(B) A wholesale distributor to a chain pharmacy warehouse to
that chain pharmacy warehouse’s intracompany pharmacy to a patient
or other designated persons authorized by law to dispense or
administer such prescription drug to a patient; or

(C) A chain pharmacy warehouse to that chain pharmacy
warehouse’s intracompany pharmacy to a patient or other designated
persons authorized by law to dispense or administer such
prescription drug to a patient; or

(D) As prescribed by the board’s rules.

(50) "Patient counseling" means the oral communication by the
pharmacist of information, as defined in the rules of the board, to
the patient to improve therapy by aiding in the proper use of drugs
and devices.

(51) “Pedigree” means a statement or record in a written form
or electronic form, approved by the board, that records each
wholesale distribution of any given prescription drug (excluding
veterinary prescription drugs), which leaves the normal
distribution channel.

(52) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.

(53) "Pharmaceutical care" is the provision of drug therapy
and other pharmaceutical patient care services intended to achieve
outcomes related to the cure or prevention of a disease,
elimination or reduction of a patient's symptoms or arresting or
slowing of a disease process as defined in the rules of the board.

(54) "Pharmacist" means an individual currently licensed by
this state to engage in the practice of pharmaceutical care.

(55) “Pharmacist care” is the provision by a pharmacist of
medication therapy management services, with or without the
dispensing of drugs or devices, intended to achieve outcomes
related to the cure or prevention of a disease, elimination or
reduction of a patient’s symptoms, or arresting or slowing of a
disease process, as defined in the rules of the board.

(56) "Pharmacist-in-charge" means a pharmacist currently
licensed in this state who accepts responsibility for the operation
of a pharmacy in conformance with all laws and rules pertinent to
the practice of pharmacy and the distribution of drugs and who is
personally in full and actual charge of the pharmacy and personnel.

(57) "Pharmacist's scope of practice pursuant to the
collaborative pharmacy practice agreement" means those duties and
limitations of duties placed upon the pharmacist by the
collaborating physician, as jointly approved by the Board and the
Board of Medicine or the Board of Osteopathy.

(58) "Pharmacy" means any drugstore, apothecary or place
within this state where drugs are dispensed and sold at retail or
displayed for sale at retail and pharmaceutical care is provided
and any place outside of this state where drugs are dispensed and
pharmaceutical care is provided to residents of this state.

(59) “Pharmacy intern” or “intern” means an individual who is
currently licensed to engage in the practice of pharmacy while
under the supervision of a pharmacist.

(61) "Physician" means an individual currently licensed, in
good standing and without restrictions, as an allopathic physician
by the West Virginia Board of Medicine or an osteopathic physician
by the West Virginia Board of Osteopathy.

(62) “Practice of telepharmacy” means the provision of
pharmacist care by properly licensed pharmacists located within
jurisdictions of the United States through the use of
telecommunications or other technologies to patients or their
agents at a different location that are located within US
jurisdictions.

(63) "Practitioner" means an individual authorized by a
jurisdiction of the United States to prescribe and administer drugs
in the course of professional practices, including allopathic and
osteopathic physicians, dentists, physician assistants,
optometrists, veterinarians, podiatrists and nurse practitioners as
allowed by law.

(64) "Prescription drug" or "legend drug" means a drug which,
under federal law, is required, prior to being dispensed or
delivered, to be labeled with either of the following statements:

(A) “Rx Only”; or

(B) "Caution: Federal law prohibits dispensing without
prescription"; or

(C) "Caution: Federal law restricts this drug to use by, or
on the order of, a licensed veterinarian" or is a drug which is
required by any applicable federal or state law or rule to be
dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only.

(65) "Prescription drug order" means a lawful order from a
practitioner for a drug or device for a specific patient, including
orders derived from collaborative pharmacy practice, where a valid
patient-practitioner relationship exists, that is communicated to
a Pharmacist in a licensed pharmacy.

(66)"Primary care" is the first level of contact of
individuals, the family, and the community with the health care
delivery system, bringing health care as close as possible to where
people live and work, and constitutes the first element of a
continuing health care process. (Areas of primary care where
pharmacists provide pharmacist care include, but are not limited
to, the following: chronic disease management; smoking cessation;
maternal and child health; immunizations; family planning;
self-care consulting; drug selection under protocol; treatment of
common diseases and injuries; nutrition; and general health
education and promotion.)

(67)"Product labeling" means all labels and other written,
printed, or graphic matter upon any article or any of its
containers or wrappers, or accompanying such article.

(68) “Repackage” means changing the container, wrapper,
quantity, or product labeling of a drug or device to further the
distribution of the drug or device.

(69) “Repackager” means a person who repackages.

(70) "Substitute" means to dispense without the prescriber's
express authorization a therapeutically equivalent generic drug
product in the place of the drug ordered or prescribed.

(71) “Third-party logistics provider” means an entity that:

(A) Provides or coordinates warehousing, distribution, or
other services on behalf of a manufacturer, but does not take title
to the prescription drug or have general responsibility to direct
the prescription drug’s sale or disposition; and

(B) Is licensed as a wholesale distributor under this chapter.

(72) “Valid patient-practitioner relationship” means the
following have been established:

(A) A patient has a medical complaint;

(B) A medical history has been taken;

(C) A face-to-face physical examination adequate to establish
the medical complaint has been performed by the prescribing
practitioner or in the instances of telemedicine through
telemedicine practice approved by the appropriate practitioner
board; and

(D) Some logical connection exists between the medical
complaint, the medical history, and the physical examination and
the drug prescribed.

(73) “Wholesale distribution” means the distribution of
prescription drugs or devices by wholesale distributors to persons
other than consumers or patients, and includes the transfer of
prescription drugs by a pharmacy to another pharmacy if the value
of the goods transferred exceeds five percent of total prescription
drug sales revenue of either the transferor or transferee pharmacy
during any consecutive twelve-month period. Wholesale distribution
does not include:

(A) The sale, purchase, or trade of a prescription drug or
device, an offer to sell, purchase, or trade a prescription drug or
device, or the dispensing of a prescription drug or device pursuant
to a prescription;

(B) The sale, purchase, or trade of a prescription drug or
device or an offer to sell, purchase, or trade a prescription drug
or device for emergency medical reasons;

(C) Intracompany transactions, unless in violation of own use
provisions;

(D) The sale, purchase, or trade of a prescription drug or
device or an offer to sell, purchase, or trade a prescription drug
or device among hospitals, chain pharmacy warehouses, pharmacies,
or other health care entities that are under common control;

(E) The sale, purchase, or trade of a prescription drug or
device or the offer to sell, purchase, or trade a prescription drug
or device by a charitable organization described in Section
503(c)(3) of the Internal Revenue Code of 1954 to a nonprofit
affiliate of the organization to the extent otherwise permitted by
law;

(F) The purchase or other acquisition by a hospital or other
similar health care entity that is a member of a group purchasing
organization of a prescription drug or device for its own use from
the group purchasing organization or from other hospitals or
similar health care entities that are members of these
organizations;

(H) The sale, purchase, or trade of blood and blood components
intended for transfusion;

(I) The return of recalled, expired, damaged, or otherwise
non-salable prescription drugs, when conducted by a hospital,
health care entity, pharmacy, or charitable institution in
accordance with the board’s rules; or

(J) The sale, transfer, merger, or consolidation of all or
part of the business of a retail pharmacy or pharmacies from or
with another retail pharmacy or pharmacies, whether accomplished as
a purchase and sale of stock or business assets, in accordance with
the board’s rules.

(a) The West Virginia Board of Pharmacy is continued. The
members of the board in office on July 1, 2011, shall, unless
sooner removed, continue to serve until their respective terms
expire and until their successors have been appointed and
qualified.

(b) The Governor, by and with the advice and consent of the
Senate, shall appoint:

(1) Five members who are licensed to practice pharmacy in this
state; and,

(2) Two citizen members, who are not licensed under this
article, and who do not perform any services related to the
practice of the professions regulated under this article.

(d) After the initial appointment term, the appointment term
is five years. A member may not serve more than two consecutive
terms. A member who has served two consecutive full terms may not
be reappointed for at least one year after completion of his or her
second full term. A member may continue to serve until his or her
successor has been appointed and qualified.

(e) Each licensed member of the board, at the time of his or
her appointment, must have held a license in this state for a
period of not less than three years immediately preceding the
appointment.

(f) Each member of the board must be a resident of this state
during the appointment term.

(g) A vacancy on the board shall be filled by appointment by
the Governor for the unexpired term of the member whose office is
vacant.

(h) The Governor may remove any member from the board for
neglect of duty, incompetency or official misconduct.

(i) A licensed member of the board immediately and
automatically forfeits membership to the board if his or her
license to practice is suspended or revoked in any jurisdiction.

(j) A member of the board immediately and automatically
forfeits membership to the board if he or she is convicted of a
felony under the laws of any jurisdiction or becomes a nonresident
of this state.

(k) The board shall elect annually one of its members as
president, one member as vice-president and one member as treasurer
who shall serve at the will and pleasure of the board.

(l) Each member of the board is entitled to receive
compensation and expense reimbursement in accordance with article
one of this chapter.

(m) A majority of the members of the board constitutes a
quorum.

(n) The board shall hold at least two meetings annually. Other
meetings shall be held at the call of the chairperson or upon the
written request of three members, at the time and place as
designated in the call or request.

(o) Prior to commencing his or her duties as a member of the
board, each member shall take and subscribe to the oath required by
section five, article four of the Constitution of this state.

(p) The members of the board when acting in good faith and
without malice shall enjoy immunity from individual civil liability
while acting within the scope of their duties as board members.

§30-5-5. Powers and duties of the board.

The board has all the powers and duties set forth in this
article, by rule, in article one of this chapter and elsewhere in
law, including:

(7) Prepare, conduct, administer and grade written, oral or
written and oral examinations for a license, certificate and
registration;

(9) Contract with third parties to administer the examinations
required under this article;

(10) Maintain records of the examinations the board or a third
party administers, including the number of persons taking the
examination and the pass and fail rate;

(11) Maintain an office, and hire, discharge, establish the
job requirements and fix the compensation of employees and contract
with persons necessary to enforce this article. Inspectors shall
be licensed pharmacists;

(12) Investigate alleged violations of this article,
legislative rules, orders and final decisions of the board;

(13) Conduct disciplinary hearings of persons regulated by the
board;

(14) Determine disciplinary action and issue orders;

(15) Institute appropriate legal action for the enforcement of
this article;

(16) Maintain an accurate registry of names and addresses of
all persons regulated by the board;

(17) Keep accurate and complete records of its proceedings,
and certify the same as may be necessary and appropriate;

(18) Propose rules in accordance with article three, chapter
twenty-nine-a of this code to implement this article;

(19) Sue and be sued in its official name as an agency of this
state;

(20) Confer with the Attorney General or his or her assistant
in connection with legal matters and questions; and

(21) Take all other actions necessary and proper to effectuate
the purposes of this article.

§30-5-6. Rule-making authority.

(a) The board shall propose rules for legislative approval, in
accordance with article three, chapter twenty-nine-a of this code,
to implement this article, including:

(1) Standards and requirements for a license, permit,
certificate and registration;

(2) Educational and experience requirements;

(3) Procedures for examinations and reexaminations;

(4) Requirements for third parties to prepare, administer or
prepare and administer examinations and reexaminations;

(5) The passing grade on the examination;

(6) Procedures for the issuance and renewal of a license,
permit, certificate and registration;

(7) A fee schedule;

(8) Continuing education requirements;

(9) Set standards for professional conduct;

(10) Establish equipment and facility standards for
pharmacies;

(11) Approve courses for training pharmacist technicians;

(12) Regulation of charitable clinic pharmacies;

(13) Regulation of mail order pharmacies;

(14) Agreements with organizations to form pharmacist recovery
networks;

(15) Creating an alcohol or chemical dependency treatment
program;

(16) A ratio of pharmacy technicians to on-duty pharmacist
operating in any outpatient, mail order or institutional pharmacy;

(17) Regulation of telepharmacy;

(18) The minimum standards for a charitable clinic pharmacy
and rules regarding the applicable definition of a
pharmacist-in-charge, who may be a volunteer, at charitable clinic
pharmacies: Provided, That a charitable clinic pharmacy may not be
charged any applicable licensing fees and such clinics may receive
donated drugs.

(19) Establish a formulary of generic type and brand name drug
products which are determined by the board to demonstrate
significant biological or therapeutic inequivalence and which, if
substituted, would pose a threat to the health and safety of
patients receiving prescription medication.

(20) Establish standards for substituted drug products;

(21) Establish the regulations for E-prescribing of controlled
substances;

(22) Establish the proper use of the automated Data Processing
System;

(23) Registration and control of the manufacture and
distribution of controlled substances within this State.

(24) Regulation for pharmacies;

(25) Sanitation and equipment requirements for wholesalers,
distributers and pharmacies.

(26) The procedures for denying, suspending, revoking,
reinstating or limiting the practice of a licensee, permittee,
certificate holder or registrant;

(b) The board, the Board of Medicine and the Board of
Osteopathy shall jointly agree and propose rules concerning
collaborative pharmacy practice for legislative approval in
accordance with article three, chapter twenty-nine-a of the code;

(c) The board with the advice of the Board of Medicine and the
Board of Osteopathy shall propose rules for legislative approval in
accordance with article three, chapter twenty-nine-a of this code
to perform immunizations, such as Influenza, Pneumonia, Hepatitis
A, Hepatitis B, Herpes Zoster and Tetanus on persons of eighteen
years of age or older. These rules shall provide, at a minimum,
for the following:

(1) Establishment of a course, or provide a list of approved
courses, in immunization administration. The courses must be based
on the standards established for such courses by the Centers for
Disease Control and Prevention in the public health service of the
United States Department of Health and Human Services;

(2) Definitive treatment guidelines which shall include, but
not be limited to, appropriate observation for an adverse reaction
of an individual following an immunization;

(3) Prior to administration of immunizations, a pharmacist
shall have completed a board approved immunization administration
course and completed an American Red Cross or American Heart
Association basic life-support training, and maintain certification
in the same.

(4) Continuing education requirements for this area of
practice;

(5) Reporting requirements for pharmacists administering
immunizations to report to the primary care physician or other
licensed health care provider as identified by the person receiving
the immunization;

(7) That a pharmacist may not delegate the authority to
administer immunizations to any other person; and

(8) Any other provisions necessary to implement this section.

(d) All of the board’s rules in effect on July 1, 2011, shall
remain in effect until they are amended, modified, repealed or
replaced.

§30-5-7. Fees; special revenue account; administrative fines.

(a) All fees and other moneys, except fines, received by the
board shall be deposited in a separate special revenue fund in the
State Treasury designated the “Board of Pharmacy Fund”, which fund
is continued. The fund is used by the board for the administration
of this article. Except as may be provided in article one of this
chapter, the board shall retain the amounts in the special revenue
account from year to year. Any compensation or expense incurred
under this article is not a charge against the General Revenue
Fund.

(b) The board shall deposit any amounts received as
administrative fines imposed pursuant to this article into the
General Revenue Fund of the State Treasury.

§30-5-8. Qualifications for licensure as pharmacist;

(a) To be eligible for a license to practice pharmacy under
this article, the applicant must:

(1) Submit a written application to the board;

(2) Be eighteen years of age or older;

(3) Pay all applicable fees;

(4) Graduate from a recognized school of pharmacy;

(5) Complete at least fifteen hundred hours of internship in
a pharmacy under the instruction and supervision of a pharmacist;

(6) Pass an examination approved by the board; and

(7) Not be an alcohol or drug abuser, as these terms are
defined in section eleven, article one-a, chapter twenty-seven of
this code: Provided, That an applicant in an active recovery
process, which may, in the discretion of the board, be evidenced by
participation in a twelve-step program or other similar group or
process, may be considered;

(8) Has fulfilled any other requirement specified by the board
in rule.

(b) An applicant from another jurisdiction shall comply with
all the requirements of this article.

§30-5-9. Scope practice for licensed pharmacist;

(a) The "Practice of pharmacy" means the provision of health
care related to the interpretation, evaluation, and implementation
of Medical Orders; the dispensing of prescription drug orders;
participation in drug and device selection, drug administration,
drug regimen review, drug or drug-related research, the provision
of patient counseling, the provision of those acts or services
necessary to provide pharmacist care in all areas of patient care,
including primary care and collaborative pharmacy practice and the
responsibility for compounding and labeling of drugs and devices
(except labeling by a manufacturer, repackager, or distributor of
nonprescription drugs and commercially packaged legend drugs and
devices), proper and safe storage of drugs and devices, maintenance
of proper records, and proper counseling to the patient concerning
the therapeutic value and proper use of drugs and devices. The
practice of pharmacy also includes continually optimizing patient
safety and quality of services through effective use of emerging
technologies and competency-based training.

(b) A pharmacist licensed under this article and meeting the
requirements as promulgated by legislative rule may administer
immunizations.

§30-5-10. Certification of pharmacy technicians;

(a) To be eligible for a certification as a pharmacy
technician to assist in the practice pharmacy, the applicant must:

(1) Submit a written application to the board;

(2) Be at least eighteen years of age;

(3) Pay the applicable fees;

(4) Have graduated from high school or obtained a Certificate
of General Educational Development (GED) or equivalent;

(5) Have:

(A) Graduated from a competency-based pharmacy technician
education and training program approved by the board; or

(B)Completed a site-specific, competency-based education and
training program approved by the board;

(6)Have successfully passed an examination developed using
nationally recognized and validated psychometric and pharmacy
practice standards approved by the board;

(7) Not be an alcohol or drug abuser, as these terms are
defined in section eleven, article one-a, chapter twenty-seven of
this code: Provided, That an applicant in an active recovery
process, which may, in the discretion of the board, be evidenced by
participation in a twelve-step program or other similar group or
process, may be considered;

(8) Not have been convicted of a felony in any jurisdiction
within ten years preceding the date of application for license
which conviction remains unreversed;

(9) Not have been convicted of a misdemeanor or felony in any
jurisdiction if the offense for which he or she was convicted
related to the practice of pharmacy, which conviction remains
unreversed.; and

(10) Has fulfilled any other requirement specified by the
board in rule.

(b) A person whose license to practice pharmacy has been
denied, revoked, suspended, or restricted for disciplinary purposes
in any jurisdiction is not eligible to be certified as a pharmacy
technician.

§30-5-11. Scope practice for certified pharmacy technician;

(a) A certified pharmacy technician, under the supervision of
the licensed pharmacist, may, but is not limited to, perform the
following:

(b) Indirect supervision of a certified pharmacy technician is
permitted to allow a pharmacist to take a break of no more than
thirty minutes. The pharmacist may leave the pharmacy area but may
not leave the building during the break.

(c) When a pharmacist is on break, a pharmacy technician may
continue to prepare prescriptions for the pharmacist’s
verification. A prescription may not be delivered until the
pharmacist has verified the accuracy of the prescription, and
counseling, if required, has been provided to or refused by the
patient.

(d) A pharmacy that permits indirect supervision of pharmacy
technician during a pharmacist’s break shall have either an
interactive voice response system or a voice mail system installed
on the pharmacy phone line in order to receive new prescription
orders and refill authorizations during the break.

(e) The pharmacy shall establish protocols that require a
certified pharmacy technician to interrupt the pharmacist’s break
if an emergency arises.

§30-5-12. Pharmacist interns.

(a) To be eligible for a license to assist in the practice of
pharmacy as a pharmacy intern, the applicant must be:

(1) Enrolled in a professional degree program of a school or
college of pharmacy that has been approved by the board and is
satisfactorily progressing toward meeting the requirements for
licensure as a pharmacist; or

(2) A graduate of an approved professional degree program of
a school or college of pharmacy or a graduate who has established
educational equivalency by obtaining a Foreign Pharmacy Graduate
Examination Committee Certificate, who is currently licensed by the
board for the purpose of obtaining practical experience as a
requirement for licensure as a pharmacist; or

(3) A qualified applicant awaiting examination for licensure
or meeting board requirements for re-licensure; or

(4) An individual participating in a pharmacy residency or
fellowship program.

§30-5-13. Reciprocal licensure of pharmacists from other states or countries.

(a) The board may by reciprocity license pharmacists in this
state who have been authorized to practice pharmacy in another
state: Provided, That the applicant for licensure meets the
requirements of the rules for reciprocity promulgated by the board
in accordance with chapter twenty-nine-a of this code: Provided,
however, That reciprocity is not authorized for pharmacists from
another state where that state does not permit reciprocity to
pharmacists licensed in West Virginia.

(b) The board may refuse reciprocity to pharmacists from
another country unless the applicant qualifies under the
legislative rules as may be promulgated by the board for licensure
of foreign applicants.

§30-5-14. Renewal requirements.

(a) All persons regulated by this article shall annually or
biannually, renew his or her authorization by completing a form
prescribed by the board and submitting any other information
required by the board.

(b) The board shall charge a fee for each renewal of an
authorization and shall charge a late fee for any renewal not paid
by the due date.

(c) The board shall require as a condition of renewal that
each licensee or certificate holder complete continuing education.

(d) The board may deny an application for renewal for any
reason which would justify the denial of an original application.

(a) There is established a special volunteer pharmacist
license for pharmacists retired or retiring from the active
practice of pharmaceutical care who wish to donate their expertise
for the pharmaceutical care and treatment of indigent and needy
patients in the clinic setting of clinics organized, in whole or in
part, for the delivery of health care services without charge. The
special volunteer pharmacist license shall be issued by the West
Virginia Board to pharmacists licensed or otherwise eligible for
licensure under this article and the legislative rules promulgated
hereunder without the payment of an application fee, license fee or
renewal fee, and the initial license shall be issued for the
remainder of the licensing period, and renewed consistent with the
boards other licensing requirements. The board shall develop
application forms for the special license provided in this
subsection which shall contain the pharmacist’s acknowledgment
that:

(1) The pharmacist’s practice under the special volunteer
pharmacist license will be exclusively devoted to providing
pharmaceutical care to needy and indigent persons in West Virginia;

(2) The pharmacist will not receive any payment or
compensation, either direct or indirect, or have the expectation of
any payment or compensation, for any pharmaceutical services
rendered under the special volunteer pharmacist license;

(3) The pharmacist will supply any supporting documentation
that the board may reasonably require; and

(4) The pharmacist agrees to continue to participate in
continuing professional education as required by the board for the
special volunteer pharmacist license.

(b) Any pharmacist who renders any pharmaceutical service to
indigent and needy patients of a clinic organized, in whole or in
part, for the delivery of health care services without charge under
a special volunteer pharmacist license authorized under subsection
(a) of this section without payment or compensation or the
expectation or promise of payment or compensation is immune from
liability for any civil action arising out of any act or omission
resulting from the rendering of the pharmaceutical service at the
clinic unless the act or omission was the result of the
pharmacist’s gross negligence or willful misconduct. In order for
the immunity under this subsection to apply, there must be a
written agreement between the pharmacist and the clinic pursuant to
which the pharmacist will provide voluntary uncompensated
pharmaceutical services under the control of the clinic to patients
of the clinic before the rendering of any services by the
pharmacist at the clinic: Provided, That any clinic entering into
such written agreement is required to maintain liability coverage
of not less than $1 million per occurrence.

(c) Notwithstanding subsection (b) of this section, a clinic
organized, in whole or in part, for the delivery of health care
services without charge is not relieved from imputed liability for
the negligent acts of a pharmacist rendering voluntary
pharmaceutical services at or for the clinic under a special
volunteer pharmacist license authorized under subsection (a) of
this section.

(d) For purposes of this section “otherwise eligible for
licensure” means the satisfaction of all the requirements for
licensure as listed in section five of this article and in the
legislative rules promulgated thereunder, except the fee
requirements of subsection (b) of that section and of the
legislative rules promulgated by the board relating to fees.

(e) Nothing in this section may be construed as requiring the
board to issue a special volunteer pharmacist license to any
pharmacist whose license is or has been subject to any disciplinary
action or to any pharmacist who has surrendered a license or caused
such license to lapse, expire and become invalid in lieu of having
a complaint initiated or other action taken against his or her
license, or who has elected to place a pharmacist license in
inactive status in lieu of having a complaint initiated or other
action taken against his or her license, or who has been denied a
pharmacist license.

(f) Any policy or contract of liability insurance providing
coverage for liability sold, issued or delivered in this state to
any pharmacist covered under this article shall be read so as to
contain a provision or endorsement whereby the company issuing such
policy waives or agrees not to assert as a defense on behalf of the
policyholder or any beneficiary thereof, to any claim covered by
the terms of such policy within the policy limits, the immunity
from liability of the insured by reason of the care and treatment
of needy and indigent patients by a pharmacist who holds a special
volunteer pharmacist license.

For a pharmacist to participate in a collaborative pharmacy
practice agreement, the pharmacist must:

(1) Have an unrestricted and current license to practice as a
pharmacist in West Virginia;

(2) Have at least $1 million of professional liability
insurance coverage;

(3) Meet one of the following qualifications, at a minimum:

(A) Earned a Certification from the Board of Pharmaceutical
Specialties, is a Certified Geriatric Practitioner, or has
completed an American Society of Health System Pharmacists(ASHP)
accredited residency program, which includes two years of clinical
experience approved by the boards;

(B) Successfully completed the course of study and holds the
academic degree of Doctor of Pharmacy and has three years of
clinical experience approved by the board and has completed an
Accreditation Council for Pharmacy Education (ACPE) approved
certificate program in the area of practice covered by the
collaborative pharmacy practice agreement; or

(C) Successfully completed the course of study and holds the
academic degree of Bachelor of Science in Pharmacy and has five
years of clinical experience approved by the boards and has
completed two ACPE approved certificate programs with at least one
program in the area of practice covered by a collaborative pharmacy
practice agreement.

§30-5-17. Collaborative pharmacy practice agreement.

(a) A pharmacist engaging in collaborative pharmacy practice
shall have on file at his or her place of practice the
collaborative pharmacy practice agreement. The existence and
subsequent termination of the agreement and any additional
information the rules may require concerning the agreement,
including the agreement itself, shall be made available to the
appropriate licensing board for review upon request. The agreement
may allow the pharmacist, within the pharmacist’s scope of practice
pursuant to the collaborative pharmacy practice agreement, to
conduct drug therapy management activities approved by the
collaborating physician. The collaborative pharmacy practice
agreement must be a voluntary process, which is a physician
directed approach, that is entered into between an individual
physician, an individual pharmacist and an individual patient or
the patient’s authorized representative who has given informed
consent.

(b) A collaborative pharmacy practice agreement may authorize
a pharmacist to provide drug therapy management. In instances
where drug therapy is discontinued, the pharmacist shall notify the
treating physician of such discontinuance in the time frame and in
the manner established by joint legislative rules. Each protocol
developed, pursuant to the collaborative pharmacy practice
agreement, shall contain detailed direction concerning the services
that the pharmacists may perform for that patient. The protocol
shall include, but need not be limited to:

(1) The specific drug or drugs to be managed by the
pharmacist;

(2) The terms and conditions under which drug therapy may be
implemented, modified or discontinued;

(3) The conditions and events upon which the pharmacist is
required to notify the physician; and

(4) The laboratory tests that may be ordered in accordance
with drug therapy management.

All activities performed by the pharmacist in conjunction with
the protocol shall be documented in the patient's medical record.
The pharmacists shall report at least every thirty days to the
physician regarding the patient's drug therapy management. The
collaborative pharmacy practice agreement and protocols shall be
available for inspection by the West Virginia Board, the West
Virginia Board of Medicine, or the West Virginia Board of
Osteopathy, depending on the licensing board of the participating
physician. A copy of the protocol shall be filed in the patient's
medical record.

(c) Collaborative pharmacy agreements shall not include the
management of controlled substances.

(d) A collaborative pharmacy practice agreement, meeting the
requirements herein established and in accordance with joint rules,
shall be allowed in the hospital setting, the nursing home setting,
the medical school setting and the hospital community and
ambulatory care clinics. The pharmacist shall be employed by or
under contract to provide services to such hospital, nursing home
or medical school, or hold a faculty appointment with one of the
schools of pharmacy or medicine in this state.

(e) Up to five pilot project sites in the community based
pharmacy setting which meet the requirements established in rule
shall be jointly selected by the Board, Board of Medicine and the
Board of Osteopathy.

§30-5-18. Authorizations must be displayed.

(a) The board shall prescribe the form for an authorization,
and may issue a duplicate upon payment of a fee.

(b) Any person regulated by the article must conspicuously
display his or her authorization at his or her principal business.

(a) All persons, whether licensed pharmacists or not, shall be
responsible for the quality of all drugs, chemicals and medicines
they may sell or dispense, with the exception of those sold in or
dispensed unchanged from the original retail package of the
manufacturer, in which event the manufacturer shall be responsible.

(b) Except as provided in section twenty three of this
article, the following acts shall be prohibited: (1) The
falsification of any label upon the immediate container, box and/or
package containing a drug; (2) the substitution or the dispensing
of a different drug in lieu of any drug prescribed in a
prescription without the approval of the practitioner authorizing
the original prescription: Provided, That this shall not be
construed to interfere with the art of prescription compounding
which does not alter the therapeutic properties of the prescription
or appropriate generic substitute; and (3) the filling or refilling
of any prescription for a greater quantity of any drug or drug
product than that prescribed in the original prescription without
a written or electronic order or an oral order reduced to writing,
or the refilling of a prescription without the verbal, written or
electronic consent of the practitioner authorizing the original
prescription.

§30-5-20. Generic drug products.

(a) A pharmacist who receives a prescription for a brand name
drug or drug product shall substitute a less expensive equivalent
generic name drug or drug product unless in the exercise of his or
her professional judgment the pharmacist believes that the less
expensive drug is not suitable for the particular patient:
Provided, That no substitution may be made by the pharmacist where
the prescribing practitioner indicates that, in his or her
professional judgment, a specific brand name drug is medically
necessary for a particular patient.

(b) A written prescription or electronic prescription order
shall permit the pharmacist to substitute an equivalent generic
name drug or drug product except where the prescribing practitioner
has indicated in his or her own handwriting the words "Brand
Medically Necessary." The following sentence shall be printed on
the prescription form. "This prescription may be filled with a
generically equivalent drug product unless the words 'Brand
Medically Necessary' are written, in the practitioner's own
handwriting, on this prescription form.": Provided, That "Brand
Medically Necessary" may be indicated on the prescription order
other than in the prescribing practitioner's own handwriting unless
otherwise required by federal mandate.

(c) A verbal prescription order shall permit the pharmacist to
substitute an equivalent generic name drug or drug product except
where the prescribing practitioner shall indicate to the pharmacist
that the prescription is "Brand Necessary" or "Brand Medically
Necessary." The pharmacist shall note the instructions on the file
copy of the prescription or chart order form.

(d) No person may by trade rule, work rule, contract or in any
other way prohibit, restrict, limit or attempt to prohibit,
restrict or limit the making of a generic name substitution under
this section. No employer or his or her agent may use coercion or
other means to interfere with the professional judgment of the
pharmacist in deciding which generic name drugs or drug products
shall be stocked or substituted: Provided, That this section shall
not be construed to permit the pharmacist to generally refuse to
substitute less expensive therapeutically equivalent generic drugs
for brand name drugs and that any pharmacist so refusing shall be
subject to the penalties prescribed in this article.

(e) A pharmacist may substitute a drug pursuant to this
section only where there will be a savings to the buyer. Where
substitution is proper, pursuant to this section, or where the
practitioner prescribes the drug by generic name, the pharmacist
shall, consistent with his or her professional judgment, dispense
the lowest retail cost-effective brand which is in stock.

(g) Each pharmacy shall maintain a record of any substitution
of an equivalent generic name drug product for a prescribed brand
name drug product on the file copy of a written, electronic or
verbal prescription or chart order. Such record shall include the
manufacturer and generic name of the drug product selected.

(h) All drugs shall be labeled in accordance with the
instructions of the practitioner.

(i) Unless the practitioner directs otherwise, the
prescription label on all drugs dispensed by the pharmacist shall
indicate the generic name using abbreviations, if necessary, and
either the name of the manufacturer or packager, whichever is
applicable in the pharmacist's discretion. The same notation will
be made on the original prescription retained by the pharmacist.

(j) A pharmacist may not dispense a product under this section
unless the manufacturer has shown that the drug has been
manufactured with the following minimum good manufacturing
standards and practices by:

(1) Labeling products with the name of the original
manufacturer and control number;

(2) Maintaining quality control standards equal to or greater
than those of the FDA;

(3) Marking products with identification code or monogram; and

(4) Labeling products with an expiration date.

(k) No pharmacist may substitute a generic-named
therapeutically equivalent drug product for a prescribed brand name
drug product if the brand name drug product or the generic drug
type is listed on the formulary established by the board pursuant
to this article or is found to be in violation of the requirements
of the FDA.

(l) A pharmacist who substitutes any drug shall, either
personally or through his or her agent, assistant or employee,
notify the person presenting the prescription of such substitution.
The person presenting the prescription shall have the right to
refuse the substitution. Upon request the pharmacist shall relate
the retail price difference between the brand name and the drug
substituted for it.

(m) Every pharmacy shall post in a prominent place that is in
clear and unobstructed public view, at or near the place where
prescriptions are dispensed, a sign which shall read: "West
Virginia law requires pharmacists to substitute a less expensive
generic-named therapeutically equivalent drug for a brand name
drug, if available, unless you or your physician direct otherwise."
The sign shall be printed with lettering of at least one and
one-half inches in height with appropriate margins and spacing as
prescribed by the board.

(n) Any person shall have the right to file a complaint with
the board regarding any violation of this article. Such complaints
shall be investigated by the board.

(o) Fifteen days after the board has notified, by registered
mail, a person that such person is suspected of being in violation
of this section, the board shall hold a hearing on the matter.

(p) A pharmacist complying with this section may not be liable
in any way for the dispensing of a generic-named therapeutically
equivalent drug, substituted under this section, unless the
generic-named therapeutically equivalent drug was incorrectly
substituted.

(q) In no event where the pharmacist substitutes a drug under
this section shall the prescribing physician be liable in any
action for loss, damage, injury or death of any person occasioned
by or arising from the use of the substitute drug unless the
original drug was incorrectly prescribed.

(r) Failure of a practitioner to specify that a specific brand
name is necessary for a particular patient does not constitute
evidence of negligence unless the practitioner had reasonable cause
to believe that the health of the patient required the use of a
certain product and no other.

(b) A person desiring to operate, maintain, open or establish
a pharmacy shall be registered with the board:

(c) To be eligible for a registration to operate, maintain,
open or establish a pharmacy the applicant must:

(1) Submit a written application to the board;

(2) Pay all applicable fees;

(3) Designate a Pharmacist-in-charge;

(4) Successfully complete an inspection by the board.

(d) A separate application shall be made and separate permits
shall be issued for each location.

(e) Permits are not be transferable.

(f) Permits expire and shall be renewed annually.

(g) If a permit expires, the pharmacy shall be reinspected and
an inspection fee is required.

(h) A registrant shall employ a pharmacist-in-charge and
operate in compliance with the legislative rules governing the
practice of pharmacy and the operation of a pharmacy.

(i) This section does not apply to the sale of nonprescription
drugs which are not required to be dispensed pursuant to a
practitioner's prescription.

§30-5-22. Pharmacist-in-charge.

(a) A pharmacy shall be under the direction and supervision of
a licensed pharmacist who shall be designated by the owner of the
pharmacy as the pharmacist-in-charge. This designation must be
filed with the board within thirty days of the designation.

(b) The pharmacist-in-charge is responsible for the pharmacy's
compliance with state and federal pharmacy laws and regulations and
for maintaining records and inventory.

(c) A pharmacist-in-charge may not hold such designated
position at more than one pharmacy, whether within or without the
State of West Virginia.

(d) An interim pharmacist-in-charge may be designated for a
period not to exceed sixty days. The request for an interim
pharmacist-in-charge shall detail the circumstances which warrant
such a change. This change in designation shall be filed with the
board within thirty days of the designation.

§30-5-23. Permits for mail-order houses.

(a) A mail-order house which dispenses drugs shall register
with the board.

(b) A mail-order house shall submit the application for the
permit to the board. The application shall contain the following
information:

(1) The owner of the mail-order house, whether an individual,
a partnership or a corporation;

(2) The names and titles of all individual owners, partners or
corporate officers;

(3) The pharmacy manager;

(4) The pharmacist-in-charge; and

(5) The complete address, telephone number and fax number of
the mail-order house.

(c) This section does not apply to any mail-order house which
operates solely as a wholesale distributor.

(a) No drugs or shall be manufactured, made, produced, packed,
packaged or prepared within the state, except under the personal
supervision of a pharmacist or other person as may be approved by
the board;

(b) No person shall manufacture, package or prepare a drug
without obtaining a permit from the board.

(c) Any person, who offers for sale, sells, offers for sale
through the method of distribution any legend drugs is subject to
this article.

(d) The application for a permit shall be made on a form to be
prescribed and furnished by the board and shall be accompanied by
an application fee.

(f) Separate applications shall be made and separate permits
issued for each separate place of manufacture, distribution,
making, producing, packing, packaging or preparation.

§30-5-25. Filling of prescriptions more than one year after issuance.

No prescription order may be dispensed after twelve months
from the date of issuance by the practitioner. A pharmacist may
fill the prescription after twelve months if the prescriber
confirms to the pharmacist that he or she still wants the
prescription filled and the pharmacist documents upon the
prescription that the confirmation was obtained.

§30-5-26. Partial filling of prescriptions.

(a) The partial filling of a prescription for a controlled
substance listed in Schedule II is permissible if the pharmacist is
unable to supply the full quantity called for in a written or
emergency oral prescription and the pharmacist makes a notation of
the quantity supplied on the face of the written prescription or on
the written record of the emergency oral prescription. The
remaining portion of the prescription may be filled within
seventy-two hours of the first partial filling: Provided, That if
the remaining portion is not or cannot be filled within the
seventy-two hour period, the pharmacist shall so notify the
prescribing individual practitioner. No further quantity may be
supplied beyond seventy-two hours without a new prescription.

(b) The partial filling of an electronic prescription for a
controlled substance listed in Schedule II is permissible if the
pharmacist is unable to supply the full quantity called for in an
electronic prescription and the pharmacist makes a notation on the
quantity supplied within the electronic record. The remaining
portion of the prescription may be filled consistent with the
limitations set forth in subsection (a) of this section.

(a) As used in this section, "long-term care facility" or
"LTCF" means any nursing home, personal care home, or residential
board and care home as defined in section two, article five-c,
chapter sixteen of this code which provides extended health care to
resident patients: Provided, That the care or treatment in a
household, whether for compensation or not, of any person related
by blood or marriage, within the degree of consanguinity of second
cousin to the head of the household, or his or her spouse, may not
be deemed to constitute a nursing home, personal care home or
residential board and care home within the meaning of this article.
This section does not apply to:

(1) Hospitals, as defined under section one, article five-b,
chapter sixteen of this article or to extended care facilities
operated in conjunction with a hospital;

(2) State hospitals as defined in section six, article one,
chapter twenty-seven of this code and state institutions as defined
in section three, article one, chapter twenty-five of this code;

(3) Nursing homes operated by the federal government;

(4) Facilities owned or operated by the state government;

(5) Institutions operated for the treatment and care of
alcoholic patients;

(6) Offices of physicians; or

(7) Hotels, boarding homes or other similar places that
furnish to their guests only a room and board.

(b) As used in this section, "terminally ill" means that an
individual has a medical prognosis that his or her life expectancy
is six months or less.

(c) Schedule II prescriptions for patients in a LTCF and for
terminally ill patients shall be valid for a period of sixty days
from the date of issue unless terminated within a shorter period by
the discontinuance of the medication.

(d) A prescription for a Schedule II controlled substance
written for a patient in a LTCF or for a terminally ill patient may
be filled in partial quantities, including, but not limited to,
individual dosage units. The total quantity of Schedule II
controlled substances dispensed in all partial filling shall not
exceed the total quantity prescribed.

(1) If there is any question whether a patient may be
classified as having a terminal illness, the pharmacist shall
contact the prescribing practitioner prior to partially filling the
prescription.

(2) Both the pharmacist and the prescribing practitioner have
a corresponding responsibility to assure that the controlled
substance is for a terminally ill patient.

(e) The pharmacist shall record on the prescription that the
patient is "terminally ill" or a "LTCF patient". A prescription
that is partially filled and does not contain the notation
"terminally ill" or "LTCF patient" shall be deemed to have been
filled in violation of section three hundred eight, article three,
chapter sixty-a of this code.

(f) For each partial filling, the dispensing pharmacist shall
record on the back of the prescription, or on another appropriate
record which is readily retrievable, the following information:

(1) The date of the partial filling;

(2) The quantity dispensed;

(3) The remaining quantity authorized to be dispensed; and

(4) The identification of the dispensing pharmacist.

(g) Information pertaining to current Schedule II
prescriptions for terminally ill and LTCF patients may be
maintained in a computerized system if such a system has the
capability to permit either by display or printout, for each
patient and each medication, all of the information required by
this section as well as the patient's name and address, the name of
each medication, original prescription number, date of issue, and
prescribing practitioner information. The system shall also allow
immediate updating of the prescription record each time a partial
filling of the prescription is performed and immediate retrieval of
all information required under this section.

§30-5-28. Limitations of article.

(a) Nothing in this article shall be construed to prevent,
restrict or in any manner interfere with the sale of nonnarcotic
nonprescription drugs which may be lawfully sold without a
prescription in accordance with the United States Food, Drug and
Cosmetic Act or the laws of this state, nor shall any rule be
adopted by the board which shall require the sale of
nonprescription drugs by a licensed pharmacist or in a pharmacy or
which shall prevent, restrict or otherwise interfere with the sale
or distribution of such drugs by any retail merchant. The sale or
distribution of nonprescription drugs shall not be deemed to be
improperly engaging in the practice of pharmacy.

(b) Nothing in this article shall be construed to interfere
with any legally qualified practitioner of medicine, dentistry or
veterinary medicine, who is not the proprietor of the store for the
dispensing or retailing of drugs and who is not in the employ of
such proprietor, in the compounding of his or her own prescriptions
or to prevent him or her from supplying to his or her patients such
medicines as he or she may deem proper, if such supply is not made
as a sale.

(c) The exception provided in subsection (b) of this section
does not apply to an ambulatory health care facility: Provided,
That a legally licensed and qualified practitioner of medicine or
dentistry may supply medicines to patients that he or she treats in
a free clinic and that he or she deems appropriate.

§30-5-29. Actions to enjoin violations.

(a) If the board obtains information that any person has
engaged in, is engaging in or is about to engage in any act which
constitutes or will constitute a violation of this article, the
rules promulgated pursuant to this article, or a final order or
decision of the board, it may issue a notice to the person to cease
and desist in engaging in the act and/or apply to the circuit court
in the county of the alleged violation for an order enjoining the
act.

(b) The circuit courts of this state may issue a temporary
injunction pending a decision on the merits, and may issue a
permanent injunction based on its findings in the case.

(c) The judgment of the circuit court on an application
permitted by this section is final unless reversed, vacated or
modified on appeal to the West Virginia Supreme Court of Appeals.

(a) The board may initiate a complaint upon receipt of
credible information, and shall upon the receipt of a written
complaint of any person, cause an investigation to be made to
determine whether grounds exist for disciplinary action under this
article or the legislative rules promulgated pursuant to this
article.

(b) After reviewing any information obtained through an
investigation, the board shall determine if probable cause exists
that the licensee, certificate holder, registrant or permittee has
violated subsection (g) of this section or rules promulgated
pursuant to this article.

(c) Upon a finding of probable cause to go forward with a
complaint, the board shall provide a copy of the complaint to the
licensee, certificate holder, registrant or permittee.

(d) Upon a finding that probable cause exists that the
licensee, certificate holder, registrant or permittee has violated
subsection (g) of this section or rules promulgated pursuant to
this article, the board may enter into a consent decree or hold a
hearing for disciplinary action against the licensee, certificate
holder, registrant or permittee. Any hearing shall be held in
accordance with this article, and shall require a violation to be
proven by a preponderance of the evidence.

(e) Any member of the board or the executive director of the
board may issue subpoenas and subpoenas duces tecum to obtain
testimony and documents to aid in the investigation of allegations
against any person regulated by the article.

(f) Any member of the board or its executive director may sign
a consent decree or other legal document on behalf of the board.

(g) The board may, after notice and opportunity for hearing,
deny or refuse to renew, suspend, restrict or revoke the license,
certificate, registration or permit of, or impose probationary
conditions upon or take disciplinary action against, any licensee
certificate holder, registrant or permittee for any of the
following reasons:

(1) Obtaining an authorization by fraud, misrepresentation or
concealment of material facts;

(2) Being convicted of a felony or other crime involving
drugs, violent crime, or moral turpitude, or engaging in any act
involving moral turpitude or gross immorality;

(3) Being guilty of unprofessional conduct which placed the
public at risk, as defined by legislative rule of the board;

(4) Intentional violation of a lawful order or legislative
rule of the board;

(5) Having had an authorization revoked or suspended, other
disciplinary action taken, or an application for an authorization
revoked or suspended by the proper authorities of another
jurisdiction;

(6) Aiding or abetting unlicensed practice;

(7) Engaging in an act while acting in a professional capacity
which has endangered or is likely to endanger the health, welfare
or safety of the public;

(8) Incapacity that prevents a licensee or certificate holder
from engaging in the practice of pharmacy or assisting in the
practice of pharmacy, with reasonable skill, competence, and safety
to the public;

(9) Violation of any laws, including rules pertaining thereto,
of this or any other jurisdiction, relating to the practice of
pharmacy, drug samples, drug manufacturing, wholesale or retail
drug or device distribution, or controlled substances;

(10) Committing fraud in connection with the practice of
pharmacy;

(11) Disciplinary action taken by another state or
jurisdiction against an authorization to practice pharmacy based
upon conduct by the licensee, certificate holder, registrant or
permittee similar to conduct that would constitute grounds for
actions as defined in this section;

(12) Failure to report to the board any adverse action taken
by another licensing jurisdiction, government agency, law
enforcement agency, or court for conduct that would constitute
grounds for action as defined in this section;

(13) Failure to report to the board one's surrender of a
license or authorization to practice pharmacy in another
jurisdiction while under disciplinary investigation by any of those
authorities or bodies for conduct that would constitute grounds for
action as defined in this section;

(14) Failure to report to the board any adverse judgment,
settlement, or award arising from a malpractice claim arising
related to conduct that would constitute grounds for action as
defined in this section;

(15) Knowing or suspecting that a licensee or certificate
holder is incapable of engaging in the practice of pharmacy or
assisting in the practice of pharmacy, with reasonable skill,
competence, and safety to the public, and failing to report any
relevant information to the board;

(16) Illegal use or disclosure of protected health
information;

(17) Engaging in any conduct that subverts or attempts to
subvert any licensing examination or the administration of any
licensing examination;

(18) Failure to furnish to the board or its representatives
any information legally requested by the board, or failure to
cooperate with or engaging in any conduct which obstructs an
investigation being conducted by the board;

(19) Agreed to participate in a legend drug product conversion
program promoted or offered by a manufacturer, wholesaler or
distributor of such product for which the pharmacist or pharmacy
received any form of financial remuneration, or agreed to
participate in a legend drug program in which the pharmacist or
pharmacy is promoted or offered as the exclusive provider of legend
drug products or whereby in any way the public is denied, limited
or influenced in selecting pharmaceutical service or counseling; or

(20) Violation of any of the terms or conditions of any order
entered in any disciplinary action.

(h) For the purposes of subsection (g) of this section,
effective July 1, 2011, disciplinary action may include:

(1) Reprimand;

(2) Probation;

(3) Restrictions;

(4) Suspension;

(5) Revocation;

(6) Administrative fine, not to exceed $1,000 per day per
violation;

(7) Mandatory attendance at continuing education seminars or
other training;

(8) Practicing under supervision or other restriction; or

(9) Requiring the licensee, certificate holder, registrant, or
permittee to report to the board for periodic interviews for a
specified period of time.

(i) In addition to any other sanction imposed, the board may
require a licensee, certificate holder, registrant, or permittee to
pay the costs of the proceeding.

(j) The board may defer disciplinary action with regard to an
impaired licensee or certificate holder who voluntarily signs an
agreement, in a form satisfactory to the board, agreeing not to
practice pharmacy and to enter an approved treatment and monitoring
program in accordance with the board’s legislative rule. This
subsection, provided that this section should not apply to a
licensee or certificate holder who has been convicted of, pleads
guilty to, or enters a plea of nolo contendere or a conviction
relating to a controlled substance in any jurisdiction.

(l) Nothing shall be construed as barring criminal
prosecutions for violations of this article.

(m) A person authorized to practice under this article, who
reports or otherwise provides evidence of the negligence,
impairment or incompetence of another member of this profession to
the board or to any peer review organization, shall not be liable
to any person for making such a report if such report is made
without actual malice and in the reasonable belief that such report
is warranted by the facts known to him or her at the time.

§30-5-31. Procedures for hearing; right of appeal.

(a) Hearings are governed by section eight, article one of
this chapter.

(b) The board may conduct the hearing or elect to have an
administrative law judge conduct the hearing.

(c) If the hearing is conducted by an administrative law
judge, at the conclusion of a hearing he or she shall prepare a
proposed written order containing findings of fact and conclusions
of law. The proposed order may contain proposed disciplinary
actions if the board so directs. The board may accept, reject or
modify the decision of the administrative law judge.

(d) Any member or the executive director of the board has the
authority to administer oaths, examine any person under oath and
issue subpoenas and subpoenas duces tecum.

(e) If, after a hearing, the board determines the licensee,
certificate holder, registrant or permittee has violated this
article or the board's rules, a formal written decision shall be
prepared which contains findings of fact, conclusions of law and a
specific description of the disciplinary actions imposed.

§30-5-32. Judicial review.

Any person adversely affected by a decision of the board
entered after a hearing may obtain judicial review of the decision
in accordance with section four, article five, chapter
twenty-nine-a of this code, and may appeal any ruling resulting
from judicial review in accordance with article six, chapter
twenty-nine-a of this code.

§30-5-33. Criminal proceedings; penalties.

(a) When, as a result of an investigation under this article
or otherwise, the board has reason to believe that a person
authorized under this article has committed a criminal offense
under this article, the board may bring its information to the
attention of an appropriate law-enforcement official.

(b) Any person, who violates any of this article is guilty of
a misdemeanor, and, upon conviction, shall be fined not to exceed
$50 for the first offense, and upon conviction of a second offense
shall be fined not less than $50 nor more than $500, or confined in
jail not to exceed thirty days, or both fined and confined. Each
and every day that the violation continues shall constitute a
separate offense.

NOTE: The purpose of this bill is to update and revise the
law governing the practice of pharmacy. The bill prohibits the
practice of pharmacy without a license. The bill defines terms.
The bill provides for a board and its composition. The bill sets
forth the powers and duties of the board and clarifies rule-making
authority. The bill also continues a special revenue account. The
bill establishes license, certificate and registration requirements
and creates a scope of practice. Also, the bill provides for a
temporary permit, establishes renewal requirements and provides for
exemptions from licensure. The bill requires the display of a
license. Further, the bill sets forth grounds for disciplinary
actions, allows for specific disciplinary actions, provides
procedures for investigation of complaints. Additionally, the bill
provides judicial review and appeals of decisions and sets forth
hearing and notice requirements. The bill provides for civil
causes of action and providing criminal penalties. The bill also
provides for privileged communication and provides that a single
act is evidence of practice.

This article has been completely rewritten; therefore, the
entire article is underscored.